Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
282 participants
INTERVENTIONAL
2009-02-28
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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SonoVue guided biopsy
Contrast-enhanced ultrasound guided biopsy
One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part
One to four bolus (each 2.4mL) of SonoVue per patient in the main part
Systematic biopsy
ultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy
Interventions
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Contrast-enhanced ultrasound guided biopsy
One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part
One to four bolus (each 2.4mL) of SonoVue per patient in the main part
ultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Optimization part only: Diagnosis of prostate cancer
* Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
* Written Informed Consent and willing to comply with protocol requirements
Exclusion Criteria
* Known allergy to sulphur hexafluoride micro bubbles
* Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
* evolving or ongoing myocardial infarction
* typical angina at rest within the previous 7 days
* significant worsening of cardiac symptoms within the previous 7 days
* recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
* acute cardiac failure, class III/IV cardiac failure
* severe cardiac rhythm disorders
* right-to-left shunts
* Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
* Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
* Determined by the Investigator that the patient is clinically unsuitable for the study
* Participation in a concurrent clinical trial or in another trial within the past 30 days
* Repeated participation in this trial (the patient should not be enrolled twice in the present study)
40 Years
MALE
No
Sponsors
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Bracco Imaging S.p.A.
INDUSTRY
Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Maria L Storto, MD
Role: STUDY_CHAIR
Bracco Diagnostics, Inc
Locations
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Medical University Innsbruck
Innsbruck, , Austria
University Hospital K.U. Leuven
Leuven, , Belgium
Hôpital Edouard Herriot
Lyon, , France
Hôpital Necker-Enfants Malades
Paris, , France
CHRU Tours - Hôpital Bretonneau
Tours, , France
Institut für Radiologie der Charité
Berlin, , Germany
Martini-Klinik, Prostate Cancer Center
Hamburg, , Germany
Urologische Klinik und Poliklinik
Munich, , Germany
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
Bologna, , Italy
Ospedale Valduce
Como, , Italy
European Institute of Oncology
Milan, , Italy
I.R.C.C.S. San Raffaele
Milan, , Italy
University of Palermo
Palermo, , Italy
University of Trieste
Trieste, , Italy
AMC University Amsterdam
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Imperial College NHS Trust - Charing Cross
London, , United Kingdom
Countries
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Other Identifiers
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BR1-127
Identifier Type: -
Identifier Source: org_study_id
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